Landmark UK patent law change will boost clinical research

A major amendment to UK patent law has taken effect today (October 1) could help to attract drug research back to the UK.

The amendment will remove the risk of infringement claims and allow companies to use a patented product when carrying out clinical trials. The change is an addition to the existing ‘Bolar Exemption’, a European Union directive which only protected generic drugmakers from the risk of infringement lawsuits if they conducted trials on a patented product.

The new change now removes intellectual property barriers to the research-based pharmaceutical industry carrying out clinical trials in the UK, putting the country on the same level as other EU countries and with generics players.

Stephen Bennett, a partner in Hogan Lovells London IP practice, told PharmaTimes “one of the issues that drives location for clinical trials is whether that work will escape the risk of patent infringement claims, injunctions stopping trials part way through or ‘stop-go’ injunctions and damages imposed after the event”. This is now “a much more straightforward exercise to clear trials in the UK for patent purposes”, giving research-based companies “more certainty in the planning stage and removes one of the tricky issues from the matrix of factors that need to be addressed to get trials off the ground”.

He added that “although this is a move that the innovator industry will welcome, it is not clear what effect it will have when the new Unitary Patent Court comes into effect”, slated for 2015. Mr Bennett went on to say that the legislation which sets up that system “has its own Bolar provision that is squarely aimed only at trials to generate data for generic authorisation. Given that existing patents end up in this new system by default, there is potential for the revised Bolar to have a short life”.

Nicholas Jones, partner and patent attorney at Withers & Rogers, echoed Mr Bennett’s point, saying the change is good news for the UK “and it is likely to lead to more research projects taking place here”. He added “this is important because we need to retain research skills and expertise and it should also help to avoid delays when bringing new drugs and treatments to market”.